Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
調査の概要
詳細な説明
Our key background data come from the randomized study conducted by McCorkle et al.
After evaluation testing, patients will be randomly assigned (similarly to a coin toss) to one of two possible follow-up groups. One would be a regular post-surgery care group (control group), the other will have in addition a support by geriatric nurse practitioner (intervention group).
Patients who are assigned to the intervention group: once they arrive home, in addition to their normal post-surgery care, will receive a once a week home visit by a geriatric nurse practitioner (GNP). The GNP will also call the patient once a week in between. The GNP will check any problem patients may have during their recovery and provide or organize care for it. The GNP has a checklist of problems to address so that we can reliably reproduce our intervention in other patients. The GNP will work together with the patient's various doctors and caregivers, as well as a geriatric team. Some of the visits or the telephone calls maybe tape-recorded so that the research team can evaluate the information provided to the patient. We will record any complication patients might have from surgery.
No matter which treatment group the patient is assigned to, at the end of a 4 weeks period, we will repeat the tests we did at the beginning to see how they change.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Tampa、Florida、アメリカ、33612
- H. Lee Moffitt Cancer Center and Research Institute
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Colorectal cancer, stage III or IV, confirmed by histology
- Abdominal surgery by a University of South Florida (USF) surgeon at Moffitt Cancer Center or Tampa General Hospital (TGH)
- Age 60 years and older
- Informed consent
- Living within a one (1) hour radius of Moffitt
Exclusion Criteria:
- Discharge planned to a rehabilitation facility or a nursing home
- Unable to answer the questionnaires (e.g. because of cognitive impairment, blindness, deafness)
- Post-operative inpatient stay >one (1) month
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control Arm
Usual post-surgical care
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実験的：Intervention arm
In addition to usual post-surgical care, the patients will receive a 4 week geriatric nurse practitioner-centered intervention, based on the McCorkle model.
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The intervention will consist each week in a home visit and a phone call.
The GNP conducting the home visit will identify current problems using a comprehensive geriatric assessment (CGA) and record problems on the Intervention and Recommendation Data Sheet.
In addition, the cases will be reviewed at a weekly Intervention Team meeting between the intervention GNP (VM, CV), the geriatrician (VP), and the intervention PI (JO).
That team meeting will also record how intervention goals for the various problems are met, using the instruments and criteria developed during our pilot study5.
To ensure optimal consistency and an up-to-date evidence-based approach over the 4 years of the intervention, treatment recommendations will be offered according to national evidence-based treatment guidelines.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of the Intervention
時間枠：30 days per participant
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The primary end-point for the pilot will be the feasibility of the intervention, measured as follows:
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30 days per participant
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention
時間枠：30 days per participant
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Aim 2 will be judged qualitatively.
Dr. Ruth McCorkle and Dr. Janine Overcash will judge whether the intervention is faithful enough to Dr McCorkle's original intervention and whether it can be carried effectively by the trained personnel.
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30 days per participant
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A Successful Collection and Testing of >=90% of the Samples Tested
時間枠：30 days per participant
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Aim 3 will be judged by assessing the percentage of tests that could or not be performed on the Moffitt patients.
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30 days per participant
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Effect Size Estimates for Within-group Changes Between Baseline and 1-month
時間枠：30 days per participant
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Aim 4 will be assessed by the activities of daily living (ADL), instrumental activities of daily living (IADL), complications and FACT-colorectal (FACT-C) v.4 questionnaires at baseline and end of intervention.
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30 days per participant
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協力者と研究者
捜査官
- 主任研究者：Martine Extermann, M.D., Ph.D.、H. Lee Moffitt Cancer Center and Research Institute
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
大腸がんの臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
McCorkle Model Interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)積極的、募集していない
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Cliniques universitaires Saint-Luc- Université...完了
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ